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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameABBOTT HAVAB/HAVAB EIA/IMX HAVAB
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitis a virus 125i (human)
Regulation Number866.3310
ApplicantABBOTT LABORATORIES
PMA NumberP780012
Supplement NumberS011
Date Received10/03/2001
Decision Date09/05/2002
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add testing of a sensitivity panel for qualification of the hepatitis a virus extract used in the havab assays to coat the solid phase of the bead and to tighten assay acceptance specification for hav antigen qualification.
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